A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
Status:
Not yet recruiting
Trial end date:
2025-02-15
Target enrollment:
Participant gender:
Summary
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the
general population and for military veterans in particular. Several psychological and
pharmacological treatments for PTSD have evidence to support their efficacy. However, the
lack of comparative effectiveness data for PTSD treatments remains a major gap in the
literature, which limits conclusions that can be drawn about which of these treatments work
best. The current study will compare the effectiveness of PTSD treatments with the strongest
evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or
venlafaxine - as well as the combination of these two treatments. A randomized trial will be
conducted with a large, diverse sample of veterans with PTSD (N = 450) recruited from 6 VA
Medical Centers throughout the US. Participants will complete baseline assessments, followed
by an active treatment phase (involving up to 14 sessions of PE and/or medication management)
with mid (7 week) and posttreatment (14 week) assessments, and follow-up assessments at 27
and 40 weeks. Study outcomes will include PTSD severity, depression, quality of life and
functioning, assessed via clinical ratings and self-report measures. Further, a range of
demographic and clinically relevant variables (e.g., trauma type/number, resilience) will be
collected at baseline and examined as potential predictors or moderators of treatment
response, addressing another gap in the PTSD treatment literature. These data will be used to
develop algorithms from predicting the optimal treatment for individual patients (i.e.,
"personalized advantage indices"; PAIs). Effectiveness of the treatments will be compared
using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to
select variables that predict or moderate outcomes (clinician rated PTSD severity at Week
14), followed by jacknife analyses to determine the magnitude of the predicted difference
(representing an individual's "predicted advantage" of one treatment over the others).
Phase:
Phase 4
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Coatesville VA Medical Center Corporal Michael J. Crescenz VA Medical Center Milwaukee VA Medical Center North Texas Veterans Healthcare System Patient-Centered Outcomes Research Institute San Diego Veterans Healthcare System VA Palo Alto Health Care System